About Us
At PCI Portal, we are dedicated to empowering the Life Science industry with innovative solutions and unparalleled expertise.
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Since our establishment in 1998, we have been at the forefront of providing comprehensive services tailored to the unique needs of our clients across various sectors, from Biotechnology to Semiconductor. Over the years, our commitment to excellence has led us to evolve into a trusted partner specifically serving the dynamic landscape of the Life Science sector.
Our Evolution
Originally founded to offer a One Stop E-Portal catering to diverse industries, we quickly recognized the specialized needs of the Life Science industry. With a deep understanding of the regulatory complexities and quality standards governing this sector, we transitioned our focus to become specialists in supporting MedTech and Drug Development endeavors.
Our Expertise
At PCI Portal, we pride ourselves on our team of subject matter experts, who collectively bring over 40 years of industry knowledge and experience. Whether it’s navigating intricate regulatory pathways, implementing robust quality management systems, or optimizing processes for efficiency and excellence, our experts are here to guide you every step of the way.
PCI Portal offers a wide range of Regulatory Affairs, Quality Assurance, and Operational Excellence Services. Our team bridges 40 years of combined knowledge at the forefront of your organization. The service portfolios include, but not limited to:
- Cardiovascular Devices including Drug Delivery Stents
- Class III Medical devices
- Class II medical device equipment and software
- Immunotherapy (CAR-T Cell)
- Companion Diagnostic
- In Vitro Diagnostics
- Biologics (e.g. mAb, large molecules)
- Oral Drugs and Topicals (e.g.small molecules, capsules, oinments)
- Injectables
- Vaccines
Our Services
From MedTech Regulatory Affairs to Drug Development Regulatory Affairs, and beyond, we offer a comprehensive suite of services designed to meet the diverse needs of our clients:
- MedTech Regulatory Affairs
- Quality Management Systems
- Process Improvement
- Drug Development Regulatory Affairs
Our Promise
At PCI Portal, our commitment to our clients goes beyond just delivering services. We strive to build lasting partnerships based on trust, integrity, and results. Whether you’re a startup navigating your first regulatory submission or an established firm seeking to streamline processes, we are dedicated to empowering your success every step of the way.
Connect with Us
Ready to embark on your next Life Science journey? Get in touch with us today to discover how PCI Portal can be your strategic partner for success.
